Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).

For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.

plaque progression [ Time Frame: one year ] [ Designated as safety issue: No ]

endothelial function [ Time Frame: one year ] [ Designated as safety issue: No ]

immune function [ Time Frame: one year ] [ Designated as safety issue: No ]

lipid profile [ Time Frame: one year ] [ Designated as safety issue: No ]

CRP [ Time Frame: one year ] [ Designated as safety issue: No ]

adipocytokines [ Time Frame: one year ] [ Designated as safety issue: No ]

LFT's [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Statin Therapy to Improve Atherosclerosis in HIV Patients

Official Title ICMJE

Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients

Brief Summary

In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

40

Completion Date

January 2014

Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion criteria:

Men and women age 18-60 with previously diagnosed HIV disease

Subclinical coronary artery disease as defined by presence of one or more plaque on coronary CTA without history of cardiac events or cardiac symptoms and no evidence of critical coronary stenosis. Target to background ratio (TBR) as determined by PET of > 1.6.

Stable anti-retroviral (ARV) therapy as defined by no changes in ARV regimen for >6 months

LDL-cholesterol >70 mg/dL and <130 mg/dL

Exclusion criteria:

History of acute coronary syndrome

Contraindication to statin therapy

Current statin use

AST or ALT two times greater than the upper limit of normal or receiving treatment for active liver disease

Renal disease or creatinine >1.5 mg/dL (given the risk of contrast nephropathy during CT angiography of the heart)

Infectious illness within past 3 months

Contraindication to beta-blocker (including moderate to severe asthma or heart block) or nitroglycerin use as these drugs are given as part of the standard cardiac CT protocol. Previous allergic reaction to beta blocker or nitroglycerin.

Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:

More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization

More than 2 myocardial perfusion studies within the past 12 months

More than 2 CT angiograms within the past 12 months

Any subjects with history of radiation therapy.

Patients already scheduled or being considered for a procedure or treatment requiring significant radiation exposure (e.g., radiation therapy, PCI, or catheter ablation of arrhythmia) within 12 months of randomization

Pregnancy or breastfeeding

Coronary artery luminal narrowing >70% seen on coronary CTA

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects